FDA Deems Inomas DS Drug-Delivery System Recall A Class I

Earlier this month, we wrote that Ikaria, Inc. announced that its <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">INOMAX® DS Drug-Delivery Systems in the United States were being voluntarily recalled due to the potential failure of a pressure switch, which may have an impact on the administration of INOMAX® (nitric oxide) for inhalation to patients, announced the U.S. Food and Drug Administration (FDA). The FDA has deemed this recall a Class I and is providing updated information.

Ikaria, Inc. notified healthcare professionals of the Class I Recall of the INOMAX (nitric oxide) Drug-Delivery System. Risks to the patient may include interruption of drug flow due to an empty cylinder, and/or the time taken to switch to a replacement system. An interruption or delay in the administration of INOMAX therapy may cause:
• Worsening of low blood oxygen level (hypoxemia)
• Low blood pressure (hypotension) and/or
• Increase in blood pressure in the pulmonary arteries (pulmonary hypertension)
• Death

INOMAX is a vasodilator, which, with ventilator support and other appropriate agents, is indicated for the treatment of term and near-term—less than 34 weeks gestation—neonates with hypoxic respiratory failure. If a leak is suspected, clinicians should:
• Not interrupt the delivery of INOMAX;
• Verify an adequate amount of INOMAX remains in the cylinder;
• Switch to the manual back-up system using the INOblender by connecting the INOMAX Inlet Hose of the INOblender directly to the INOMAX regulator, and follow the standard procedure for use of the INOblender as the primary back-up method for manual ventilation, and;
• Contact Ikaria Customer Care at 1-877-KNOW-INO (1-877-566-9466) for assistance.

Although the risk of INOMAX exposure to pregnant women is unknown, it is advised that healthcare professionals who may be pregnant avoid the immediate area in which a leak is suspected.
Ikaria has begun the replacement process of all INOMAX DS drug-delivery systems with remediated INOMAX DS systems. This recall does not apply to the INOvent® drug-delivery system.

Customers with questions regarding this notice may contact Ikaria Customer Care at 1¬877-KNOW-INO (1-877-566-9466) for assistance. Adverse reactions associated with the use of these products may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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